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Male erectile dysfunction
("ED") is described as the
inability to attain and maintain an
erection sufficient for sexual
intercourse. In essence, the penis has
insufficient or inadequate blood supply
and the causes may be due to
physiological impairment, psychological
factors, or a combination of the two.
Conservative estimates
suggest that 31 million men in the U.S.
are affected, and more than 140 million
men worldwide. The current ED treatment
market is estimated at $1.6 billion and
is projected to expand to $3.9 billion by
year 2005.
The Alprox-TD alprostadil
cream incorporates alprostadil (or
prostaglandin E1), an off-patent drug
that is well recognized for treating ED,
with the NexACT technology. NexMed
announced positive top-line results from
its two pivotal Phase 3 studies of
Alprox-TD cream treatment for erectile
dysfunction ("ED"). The
clinical data indicated that the three
dose levels of Alprox-TD tested were
effective over placebo in each study and
in the combined analysis of the two
studies. All doses showed a highly
significant (p= 0.001 or p 0.001)
increase in Erectile Function Domain
scores using the International Index of
Erectile Function (IIEF), the gold
standard for measuring efficacy in ED
products. The side effects reported were
mostly mild to moderate, localized and
transient. The overall discontinuance
rate due to side effects was less than
4%.
Over 1,700 patients with
mild to severe ED were enrolled in the
two pivotal Phase 3 studies. The studies,
conducted at 85 US research clinics, were
randomized, double-blind,
placebo-controlled, and were designed to
confirm the efficacy and safety of
Alprox-TD in patients with mild to severe
ED. Alprox-TD incorporates alprostadil
with NexMed's patented NexACT technology.
The studies included patients who had not
previously taken ED medications as well
as patients who had little or no success
with the currently approved oral
medications for ED. Many of these
patients also had diabetes,
prostatectomies, hypertension and other
serious medical conditions.
NexMed, Inc. (Nasdaq:
NEXM), a developer of innovative topical
treatments based on its proprietary drug
delivery technology, announced that
Alprox-TD®, its proprietary
cream treatment for erectile dysfunction
("ED") was launched in Hong
Kong under the trademark Befar®.
NexMed has been selling in China since
July 2001. In November 2001, NexMed and
its Asian licensee filed a New Drug
Application with the Health Sciences
Authority for approval to market Befar®
in Singapore.
Befar®
incorporates alprostadil, a drug well
recognized for treating ED, with the
NexACT® transdermal delivery
technology. Befar® is
manufactured in China and marketed in
China and Hong Kong by NexMed's Asian
licensee. NexMed receives royalty
payments and payments for manufacturing
supplies from its Asian licensee. In
clinical studies conducted in China,
Befar® exhibited two
advantages over the currently marketed
oral ED medication- faster onset time and
minimal side effect profile.
In the U.S., NexMed is
conducting its Phase 3 clinical
development programs for Alprox-TD®.
The multi-center trials will enroll up to
2,500 patients with mild to severe ED.
NexMed has completed a Phase 2
multi-center take home study with its
Femprox® topical treatment
for female sexual arousal disorder
("FSAD").
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